—#188626

Product

Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478

FDA product code: MOI — System, Test, Immunological, Antigen, Tumor
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K982680
Affected lot / code info: All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.

Why it was recalled

Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Siemens Healthcare issued Urgent Medical Device Correction (UMDC) via FedEx beginning on 07/06/2021. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 07/06/2021. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Change the BR assay Pack Calibration Interval on each Atellica IM analyzer from 10 days to 3 days. See Additional Information for instructions on changing the Pack Calibration Interval. All Atellica IM BR assay kit lots can continue to be utilized with the updated Pack Calibration Interval of 3 days. Continue to follow the Atellica IM BR IFU claimed 28-day On-board Stability and 32-day Lot Calibration Intervals. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Additional Information Instructions for Changing the Pack Calibration Interval on Atellica IM Analyzers Instructions for updating the BR Pack Calibration Interval from 10 days to 3 days on each Atellica IM analyzer are outlined below. 1) Sign into Atellica IM analyzer as Labmanager user level 2) In the Worklist Overview screen, move all BR results to Historical 3) In the Setup screen, select Test Definition, select IM Test Definition, and select BR Test 4) Select the Calibration Tab 5) Under Pack C

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam

Timeline

Recall initiated: 2021-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188626. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.